To hear about similar clinical trials, please enter your email below
Trial Title:
Disitamab Vedotin Combined Therapy for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations
NCT ID:
NCT05847764
Condition:
Non Small Cell Lung Cancer
ERBB2 Mutation-Related Tumors
RC48
Disitamab Vedotin
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Carboplatin
Tislelizumab
Aflutinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RC48+Tislelizumab+carboplatin
Description:
RC48+PD-1/PD-L1 inhibitor+chemo in treatment-naive patients harboring HER2 alterations
Arm group label:
Arm 1: RC48+PD-1/PD-L1 inhibitor
Intervention type:
Drug
Intervention name:
RC48+Furmonertinib, 1L
Description:
RC48+Furmonertinib in treatment-naive patients harboring EGFR mutations as well as HER2
alterations
Arm group label:
Arm 2: RC48+Furmonertinib, 1L
Intervention type:
Drug
Intervention name:
RC48+Furmonertinib, 2L+
Description:
RC48+Furmonertinib in patients who failed at least one line of standard treatment and
harboring HER2 alterations
Arm group label:
Arm 3: RC48+Furmonertinib, 2L+
Summary:
Disitamab Vedotin combined therapy locally advanced or metastatic NSCLC Patients with
HER2 Alterations.
Detailed description:
This study will explore the treatment of locally advanced or metastatic non-small cell
lung cancer with HER2 mutation, amplification, or HER2 mutation (mutation, amplification,
protein over-expression) using Disitamab Vedotin（RC48） combined with Tislelizumab or
third-generation EGFR-TKI Furmonertinib, in the aim of providing new treatment strategies
for lung cancer patients with HER2 pathway activation.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age: 18 (inclusive) or above, regardless of gender.
2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC, not
suitable for radical surgery or radiotherapy (TNM 8th Edition).".
3. Biomarker:
- Arm 1: HER2 alterations, no other driver gene mutations；
- Arm 2: EGFR mutations accompanied by HER2 alterations;
- Arm 3: HER2 gene mutations, no other driver gene alterations;
4. Number of treatment lines:
- Arm 1-2: patients who have not previously received systemic treatment for
advanced diseases;
- Arm3:Failed with at least one line of standard treatment or intolerance;
5. Patients who have previously undergone neoadjuvant chemotherapy, adjuvant
chemotherapy, radiotherapy, or radiochemotherapy for the purpose of curing non
metastatic diseases must have a disease-free interval of 6 months from the last
chemotherapy and/or radiotherapy to the randomization date.
6. There is at least one measurable lesion that meets the definition of the RECIST 1.1
standard at baseline.
7. ECOG fitness status score: 0 or 1 point.
8. Estimated survival time ≥ 3 months.
Exclusion Criteria:
1. Central nervous system metastasis or meningeal metastasis with clinical symptoms.
2. Have a history of autoimmune diseases, immunodeficiency, including HIV positive, or
other acquired or congenital immunodeficiency diseases, or a history of organ
transplantation.
3. Active hepatitis B (hepatitis B virus titer>1000 copies/ml or 200 IU/ml); Hepatitis
C virus and syphilis infection.
4. Have undergone major organ surgery (excluding puncture biopsy) or have experienced
significant trauma within 3 weeks before the first use of the study drug.
5. Known hypersensitivity or intolerance to any component of the study protocol drug or
its excipients.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
SunYat-senU
Address:
City:
Guanzhou
Country:
China
Contact:
Last name:
Li Zhang, MD
Start date:
May 2023
Completion date:
May 2025
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05847764
